By Bob Sullivan Technology correspondent
updated 6/1/2004 6:08:37 PM ET 2004-06-01T22:08:37

The Federal Trade Commission says thousands of consumers have purchased a home HIV test that gives inaccurate results, and has obtained a court order in an attempt to stop U.S. sales of the kit.

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The two Web sites selling the "Discreet" kits, and, are based in West Vancouver, Canada -- outside the jurisdiction of U.S. courts. So sales of the allegedly defective kits continued on Tuesday.

Gregory Stephen Wong, who operates both sites, said in an interview with that the tests do produce accurate results. 

"The tests are extremely accurate," he said, adding that they are similar to tests performed in research labs. He said repeated trials have proven the tests are over 99 percent accurate, but he wouldn't provide any proof or research results.

False positives and negatives?
But FTC investigators, along with researchers from the Centers for Disease Control and Prevention, say the test simply doesn't work -- and, in fact, it gives both false positive and false negative results. While sales continue, the FTC has enlisted both Federal Express and the U.S. Customs Service to confiscate packages headed for U.S. consumers. Still, stopping all deliveries of the kits will be difficult, said FTC attorney Janet Evans.

"This is a really scary thing. That's why we felt we needed to bring all the guns out," Evans said. "Anyone who has used this kit in the past should get another test done immediately."

Evans said it's unclear how many consumers have purchased the kits since they went on sale in June 2001, but last year, at least 3,000 were shipped to the United States via Federal Express, she said. 

A temporary restraining order obtained from the U.S. District Court in Seattle two weeks ago, but just entered on Tuesday, mandates that the Web sites include a warning that sales to U.S. residents are banned. "So far, the defendants are ignoring that," Evans said.

Wong said he received the court order on May 14 and believed he had 20 days to respond; he said he will be halting sales to the United States shortly.

"We're going to get out of the American market," he said. "We're going to play ball."

Wong said he'd received letters from the Food and Drug Administration in the past requesting that he cease U.S. sales.

"It comes down to they want us to stop selling it, not that it doesn't work," Wong said.

Accused of false advertising
Information on the Web sites suggests that consumers can take a finger-prick sample of blood, mix it with a solution, and read a test cassette with results in about 5 minutes. No such home test has yet been invented, said Paul Feldman, spokesman for the National Association of People with AIDS. The only home test that's currently available requires consumers to mail their blood samples to a test lab.

The site claims that test results show the Discreet home HIV kit boasts a 99.4 percent accuracy rate. But CDC tests showed the home kit was widely inaccurate.

"It's rare that you test something and it performs this badly," Evans said. In its court filings, the FTC accuses site operators Seville Marketing, Ltd. and Wong, its owner, of false advertising and deceptive practices.

Quick HIV tests are a concern for AIDS advocacy groups. The CDC estimates that between 180,000 and 280,000 Americans are infected with HIV and don't it.  The easiest way to obtain a test is to call the CDC's National AIDS hot line at (800) 342-AIDS.

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